MAUDE Adverse Event Report: MEDIVATORS INC. ADVANTAGE PLUS; AUTOMATED ENDOSCOPE REPROCESSOR

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2019

Event Type  Injury  

Manufacturer Narrative

Medivators clinical education specialist (ces) was onsite at the facility and found incorrect parameters set for reprocessing endoscopes in their advantage plus automated endoscope reprocessor (aer).There is potential that endoscopes were not adequately high level disinfected prior to patient procedures, thus there is potential for patient cross-contamination.Medivators ces confirmed all five machines had incorrect parameters set.The machines were installed in august 2019 with the correct parameter sets.It is unknown how many endoscopes were reprocessed with the incorrect parameter settings.Medivators ces worked with the facility to correct all parameter settings in all five aers.According to the advantage plus aer user manual the operator must reference the endoscope hookup guide for the applicable part number and parameter set for each endoscope.There have been no reports of patient harm.This complaint will continue being monitored in the medivators complaint handing system.

Event Description

Medivators clinical education specialist (ces) was onsite at the facility and found incorrect parameters set for reprocessing endoscopes in their advantage plus automated endoscope reprocessor (aer).There is potential that endoscopes were not adequately high level disinfected prior to patient procedures, thus there is potential for patient cross-contamination.

• Brand Name: ADVANTAGE PLUS
• Type of Device: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; plymouth MN 55447
• Manufacturer (Section G): MEDIVATORS INC.; 14605 28th ave n; plymouth MN 55447
• Manufacturer Contact: lauren johnson ; 14605 28th ave n; plymouth, MN 55447 ; 7635533349
• MDR Report Key: 9476370
• MDR Text Key: 182725110
• Report Number: 2150060-2019-00072
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964044755
• UDI-Public: 00677964044755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other